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510(k) K811189

Device
CHEMSTRIP L
Applicant
BIODYNAMICS CORP.
510(k) number
K811189
Product code
GHD  
Decision
Substantially Equivalent (SESE)
Decision date
1981-07-27
Date received
1981-04-29
Regulation
864.7660
Classification name
Test, Leukocyte Alkaline Phosphatase
Medical specialty
Hematology
Review panel
Hematology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GHD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K904022NITRO BLUE TETRAZOLIUM REDUCTIONSigma Chemical Co.1990-12-18
K903995NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KITSigma Chemical Co.1990-12-13
K896092ALKALINE PHOSPHATASE, LEUKOCYTE, KITSigma Chemical Co.1989-11-09

Legacy Summary#

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FDA Review#

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